Quality Assurance/Regulatory Compliance_

Ubichem is ISO9001 accredited and operates to full cGMP under a comprehensive quality management strategy.

Our Quality Management System (QMS) focuses on quality management, documentation and records, materials management and laboratory controls and is based on the principles dictated in the ICH Q7A guidelines:

Clients are welcome to visit our facilities for formal or informal audits. We are happy to provide you detailed information pertaining to our quality systems.

Quality control_

The Quality Control (QC) department utilises a wide variety of analytical techniques to analyse and characterise products. The evaluation of raw materials is a critical starting point towards final product integrity. Production support is provided through in-process and intermediate testing. And of course rigorous final product release testing is performed. Our fully validated analytical laboratory complies with cGMP standards and can perform complete testing according to compendial monographs. Additionally, stability testing and degradation studies are performed following ICH Q1A (R2) guidelines. Our services include full analytical provision for IND/NDA purposes: method development, validation, reference standard qualification.

Our dedicated QC staff focuses on technical excellence and timely delivery of customer requirements. Close and frequent communication, directly with our clients’ quality control groups help to ensure that every project moves smoothly.

Visit the equipment list page for more information.